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Groups seek to bar abortion pill.(Mifeprex)(Brief Article)
2002 SEP 19 - (NewsRx.com & NewsRx.net) -- Antiabortion groups petitioned the U.S. Food and Drug Administration August 21, 2002, to halt sales of the abortion pill Mifeprex, saying the agency shouldn't have approved it almost 2 years ago.
The American Association of Pro-Life Obstetricians and Gynecologists, Christian Medical Association and Concerned Women for America argued that FDA bent its own rules in approving Mifeprex, including eliminating safeguards required during the pill's testing.
The groups called the drug dangerous for women, citing FDA's report last April of five Mifeprex users with health problems, including two who suffered ruptured ectopic pregnancies, one fatal.
Mifeprex does not abort an ectopic, or tubal, pregnancy, and is not supposed to be given to women with that life-threatening condition.
The other reports included two women with infections, one fatal, and one heart attack. The FDA hasn't determined that the drug played any role in the cases.
The FDA said it would review the petition, which puts in ...
- MIFEPREX: FDA'S FIRST 'POLITICAL' DRUG APPROVAL.
- Magazine article from: Medical Marketing & Media Dickinson, James G. November 1, 2000 700+ words
...of sober-faced FDA Commissioner Jane...of RU-486, or Mifeprex (mifepristone...the unprecedented FDA security shields...information released on Mifeprex. Because Roussel...over the years, the FDA agreed to conceal...identity and location of Mifeprex's actual manufacturer...
- Four reported deaths prompt FDA warning about Mifeprex.
- Press release article from: M2 Presswire July 20, 2005 700+ words
...reported deaths prompt FDA warning about Mifeprex(C)1994-2005 M2 COMMUNICATIONS...their patients taking Mifeprex. Previously, the FDA has received reports of...the black box labeling. Mifeprex was approved by the FDA in 2000. For more information...
- GAO: FDA's Mifeprex approval 'consistent'.(WASHINGTON INSIDER)
- Magazine article from: Medical Marketing & Media Dickinson, James G. October 1, 2008 700+ words
...Accountability Office said the FDA's approval process for Mifeprex, the RU-486 abortion...questioned aspects of the Mifeprex approval process...Critics said that Mifeprex does not fit within...The GAO reports the FDA reviewed the NDA through...
- FDA petitioned to revoke Mifeprex approval. (Washington Insider).(by American...
- Magazine article from: Medical Marketing & Media Dickinson, James G. October 1, 2002 700+ words
...groups have petitioned the FDA to impose an immediate...approval of the abortion drug Mifeprex (mifepristone) and have...studies, saying that the FDA has violated its standards...alleges that a number of the FDA's actions on Mifeprex were "arbitrary, capricious...
- GAO Issues Report on FDA's Approval and Oversight of Mifeprex
- News wire article from: Targeted News Service September 1, 2008 700+ words
...affecting U.S. interests during the week of Aug. 18 - 24: * Food and Drug Administration: Approval and Oversight of the Drug Mifeprex. GAO-08-751, Aug. 7. http://www.gao.gov/cgi-bin/getrpt?GAO-08-751Highlights - http://www...
- Food and Drug Administration: Approval and Oversight of the Drug Mifeprex.
- General Accounting Office Reports & Testimony September 1, 2008 700+ words
...and external stakeholders. FDA approved Mifeprex after evaluating the sponsor...under Subpart H was necessary. FDA approved Mifeprex, but required that the sponsor...analyzing adverse events. For Mifeprex, FDA investigated the deaths of six...
- Here are answers to your questions about Mifeprex.
- Magazine article from: Contraceptive Technology Update December 1, 2000 700+ words
...questions about Mifeprex 1. What is Mifeprex? Mifeprex is the first Food and Drug Administration-approved (FDA) early option pill providing...can take immediate action. Mifeprex is the only FDA-approved pill for ending early...
- More Than 100,000 U.S. Women Have Chosen Mifeprex for Their Non-Surgical...
- Press release article from: Business Wire September 24, 2002 700+ words
...S. women have used Mifeprex(a), the early option pill, since FDA approval in September...indicating increased use of Mifeprex by American women. Nearly...care is needed. Before Mifeprex received final FDA approval, every aspect...
